MAUDE Adverse Event Report: ARTHREX, INC. ACL TIGHTROPE WITH FIBERTAG, ABS; SMOOTH FIXATION PIN

Model Number ACL TIGHTROPE WITH FIBERTAG, ABS

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 08/30/2023

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On (b)(6) 2023, it was reported by a distributor via sems-06018540 that an ar-1588tnt acl-fibertag-tightrope abs-implant had an issue during a lca quadlink procedure on (b)(6) 2023.The tibial fibertag did not tension on one side.The fibertag was not through the tightrope since the tightrope was moving from left to right in the loop.The surgeon had to use a screw and a backup fixation to finish the acl.Nothing broke off inside the patient, and the procedure was completed successfully.This occurred during use with no patient harm.The device was not available for return.Additional information has been requested.On 9/1/2023, the distributor provided additional information via email: the surgery was completed.It was supposed to be a quadlink procedure with a button at the tibia.Instead, they used a screw from a competitor and a quattro for back up fixation.The case was delayed for 25 minutes.

• Brand Name: ACL TIGHTROPE WITH FIBERTAG, ABS
• Type of Device: SMOOTH FIXATION PIN
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 17827182
• MDR Text Key: 324591628
• Report Number: 1220246-2023-08005
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867308466
• UDI-Public: 00888867308466
• Combination Product (y/n): N
• PMA/PMN Number: K110123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACL TIGHTROPE WITH FIBERTAG, ABS
• Device Catalogue Number: AR-1588TNT
• Device Lot Number: 15078469
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/27/2023
• Date Device Manufactured: 04/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1